FDA (Devices) recall action 91383
The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.
There is potential for the footrest to detach from the patient table during use. Device intended to visualize anatomical structures by converting an Xray pattern into a visible image. The system has medical applications ranging from gastrointestinal examinations to cranial, skeletal, thoracic and lung exposures as well as examinations of the urogenital tract. The unit may also be used in emergency applications, lymphography, endoscopy, myelography, venography, arthrography, interventional radiology, digital angiography, and digital subtraction angiography (DSA). The system may be used on pe…
There is potential for the footrest to detach from the patient table during use.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Siemens Luminos X-ray imaging systems may have a footrest that detaches from the patient table during use. The manufacturer is recalling 886 units distributed worldwide.
Siemens recalls four fluoroscopy and radiographic imaging equipment models worldwide because patient table footrests may detach during clinical use, potentially causing patient injury.
Siemens Medical Solutions is recalling the AXIOM Luminos Agile patient table because the footrest may detach during use, creating a potential injury risk.